普乐沙福,普乐沙福Mozobil injection 24mg(plerixafor モゾビル皮下注)

药店国别:

产地国家:日本

处方药:

所属类别: 24毫克/1.2毫升 1瓶

包装规格: 24毫克/1.2毫升 1瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Sanofi Co.Ltd.

原产地英文商品名:mozobil(モゾビル皮下注)24mg/1.2mL 1Vial

原产地英文药品名:plerixafor

中文参考商品译名:mozobil 24毫克/1.2毫升 1瓶

中文参考药品译名:普乐沙福

曾用名:

简介

部份中文普乐沙福注射液处方资料(仅供参考)

药物分类名称:CXCR4趋化因子受体拮抗剂

批准日期:2017年2月

商标名:mozobil

一般名:プレリキサホル(Plerixafor)

化学名:1, 1'-(1, 4-Phenylenebismethylene)bis(1, 4, 8, 11-tetraazacyclotetradecane)分子式C28H54N8

分子量:502.78構造式

性 状

本品为白色至淡黄色白色固体。本产品微溶于乙醇(99.5)或甲醇,难溶于水。熔点131.5℃分配系数Log P = 0.94(1-辛醇/水)审批条件制定药品风险管理计划并适当执行。

2.由于在日本的临床试验数量非常有限,所以通过对所有病例进行使用情况调查,直到一定数量病例的数据在制造和销售之后积累, 除掌握使用该药的患者的背景资料外,还应尽快收集有关该药的安全性和有效性的数据,并采取必要措施正确使用该药。

药效药理

1. 薬理作用在源自表达CXC趋化因子受体4(CXCR4)的人急性淋巴细胞白血病的CCRF-CEM细胞系中,prelixafol抑制基质细胞衍生因子1(SDF-1)与CXCR4的结合。 在小鼠和狗中,造血干细胞被prematurer募集到外周血中。 在犬中,在用preliminarol动员的造血干细胞的自体移植后,证实了嗜中性粒细胞和血小板的植入。

2. 作用机序认为在骨髓基质细胞表面上表达的SDF-1参与将表达CXCR4的造血干细胞植入骨髓中。 认为prelixafiol与CXCR4结合并抑制CXCR4与SDF-1之间的结合,由此促进造血干细胞从骨髓募集到外周血中。

适应病症

促进造血干细胞募集到外周血中进行自体外周血造血干细胞移植。

用法与用量

与G-CSF制剂联合使用时,成人每天一次皮下注射0.24mg/kg,作为初步预备,直到外周血干细胞采集完成。

包装规格

皮下注射24毫克*1瓶

制造商和销售:赛诺菲有限公司提示,以上中文资料不够完整,使用请以原处方资料为准。

英文版说明

mobilization promoter of autologous peripheral blood stem cell transplantationOn Fe bruary 22, 2017, CXCR4 chemokine receptor antagonist preliminarxol (trade name Mozovir subcutaneous injection 24 mg) was released. This product is approved for manufacture and sales on December 19, 2016 and is listed on the drug price on February 15. Adaptation "promotion of recruitment of hematopoietic stem cells into peripheral blood for autologous peripheral blood stem cell transplantation". This drug is used in combination with Granulocyte Colony Stimulating Factor (G-CSF) preparation, and administered once daily at 0.24 mg / kg subcutaneously to adults daily until the end of the collection of peripheral blood stem cells. After the G-CSF preparation is administered daily for 4 days, this drug is administered 9 to 12 hours before the collection of peripheral blood stem cells.In the treatment of multiple myeloma (MM), non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HL), etc., myelosuppression or myeloablation using cyclophosphamide (Endoxan et al.) Etc. is performed, Transplantation of hematopoietic stem cells derived from the patient's own cell is performed for the purpose of reconstruction. For autografting, collection of hematopoietic stem cells to be transplanted is simple and peripheral blood stem cells with low possibility of contamination of tumor cells are given priority.At present, G-CSF preparations such as filgrastim (Gran et al.) And renograstim (neuro rosin) are used for collecting autologous peripheral blood stem cells for patients such as MM and NHL. However, there are patients with poor mobility who can not obtain peripheral blood stem cells sufficiently with G-CSF alone, and even in patients with good mobilization, it is necessary to perform apheresis frequently until the target cell number is reached As a result, there was a problem with a heavy burden on the patient.The CXC chemokine receptor 4 (CXCR4) is expressed on the cell membrane of the hematopoietic stem cell, and by binding with the interstitial cell-derived factor 1 (SDF-1) expressed on the surface of the bone marrow stromal cell, the hematopoietic stem cell bone marrow It is involved in engraftment in. Prerelaxol is believed to promote recruitment of hematopoietic stem cells from the bone marrow into the peripheral blood by reversibly binding to CXCR4 and inhibiting the binding between CXCR4 and SDF-1.This drug was eva luated as "a drug highly necessary for early clinical trials in Japan" at the unapproved drug use question examination meeting in June 2009. And efficacy and safety were confirmed in overseas Phase III clinical trials and preliminary Phase II clinical trials of premixed with/without preliminary/G-CSF for patients with MM and NHL. Overseas, it is approved in 54 countries and regions around the world including the EU in July 2016, including the United States in December 2008.Be careful that adverse reactions are recognized in domestic and overseas clinical trials when using. Major side effects include complex sensation·headache·diarrhea·nausea·injection site reaction·fatigue (more than 5% each) etc, and serious side effects include shock, anaphinaxis, splenomegaly and splenic rupture .

 

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